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Presentation

Tablets containing 1mg trifluoperazine as the hydrochloride
Tablets containing 5mg trifluoperazine as the hydrochloride
Oral solution containing 1mg/5ml trifluoperazine as the hydrochloride
Oral solution containing 5mg/5ml trifluoperazine as the hydrochloride

Drugs List

  • trifluoperazine 1mg tablets
  • trifluoperazine 1mg/5ml oral solution sugar-free
  • trifluoperazine 5mg tablets
  • trifluoperazine 5mg/5ml oral solution sugar-free
  • Therapeutic Indications

    Uses

    Low dosage
    Trifluoperazine is indicated as an adjunct in the short term management of anxiety states, depressive symptoms secondary to anxiety and agitation.
    Symptomatic treatment of nausea and vomiting.

    High dosage
    Trifluoperazine is indicated in the treatment of symptoms and prevention of relapse in schizophrenia and in other psychoses, especially of the paranoid type, but not in depressive psychoses.
    Adjunctive treatment in short term management of severe psychomotor agitation and of dangerously impulsive behaviour in, for example, mental subnormality.

    Dosage

    Adults

    Low dosage indications
    2mg to 4mg daily, given in divided doses according to the severity of the patient's condition.
    If necessary, increase dose to 6mg a day, but above this extrapyramidal symptoms are more likely to occur in some patients.

    High dosage indications
    Initial dose for physically fit adults: 5mg twice daily. After a week this may be increased to 15mg daily.
    If necessary further increases of 5mg may be made at three day intervals.
    When satisfactory control has been achieved, dosage should be reduced gradually, until an effective maintenance level has been established.

    As with all major tranquillisers, clinical improvement may not be evident for several weeks after starting treatment, and there may be a delay before recurrence of symptoms after stopping treatment. Gradual withdrawal is recommended.

    Elderly

    Reduce the starting dose by at least half in elderly and frail patients.

    Children

    Low dosage indications
    Children aged 12 to 18 years
    (See Dosage; Adult)
    Children aged 6 to 12 years
    Up to 4mg a day, given in divided doses.
    Children aged 3 to 5 years
    Up to 1mg a day, given in divided doses.
    Children aged less than 3 years
    Contraindicated.

    High dosage indications
    Children aged 12 to 18 years
    (See Dosage; Adult)
    Children aged under 12 years
    Initial dose: Up to 5mg daily, given in divided doses. Any subsequent increase should be made with caution at intervals of not less than three days, and taking into account age, bodyweight and severity of symptoms.

    The following alternative dosage schedule may be suitable:

    Severe nausea and vomiting unresponsive to other antiemetics
    Children aged 12 to 18 years
    1mg to 2mg (up to 3mg if necessary) twice daily.
    Children aged 6 to 12 years
    Give up to 2mg twice daily.
    Children aged 3 to 5 years
    Give up to 500micrograms twice daily.

    Short term adjunctive management of psychomotor agitation, excitement and violent or dangerously impulsive behaviour; Schizophrenia and other psychoses
    To be administered under specialist supervision.
    Children aged 12 to 18 years
    Initial dose: 5mg twice daily, increased by 5mg after one week, then at intervals of three days, according to response.

    Short term adjunctive management of severe anxiety
    To be administered under specialist supervision.
    Children aged 12 to 18 years
    1mg to 2mg twice daily. Increase to 3mg twice daily, if required.
    Children aged 6 to 12 years
    Give up to 2mg twice daily.
    Children aged 3 to 6 years
    Give up to 500micrograms twice daily.

    Patients with Renal Impairment

    Start with small doses in severe renal impairment.
    Increased risk of cerebral sensitivity.

    Patients with Hepatic Impairment

    Contraindicated in patients with hepatic damage.

    Administration

    For oral administration

    Contraindications

    Coma
    Coma due to CNS depressants

    Blood dyscrasias

    Hepatic damage

    Children under 3 years

    Phaeochromocytoma

    Uncontrolled cardiac decompensation

    Precautions and Warnings

    Frail elderly patients - reduce initial dose (Such patients can be sensitive to extrapyramidal and hypotensive effects). The balance of risks and benefit should be considered before prescribing antipsychotic drugs for elderly patients. In elderly patients with dementia, antipsychotic drugs are associated with a small increased risk of mortality and an increased risk of stroke or transient ischaemic attack. Furthermore, elderly patients are particularly susceptible to postural hypotension and to hyper and hypothermia in hot or cold weather.
    It is recommended that: Antipsychotic drugs should not be used in elderly patients to treat mild to moderate psychotic symptoms and treatment should be reviewed regularly

    Severe renal Impairment - reduce initial dose

    Pregnancy - see Pregnancy

    Breastfeeding- see Lactation

    Cardiac disease and Arrhythmias - Trifluoperazine may cause QT prolongation. Persistently prolonged QT intervals may increase the risk of malignant arrhythmias. Use with caution in patients with, a history of cardiovascular disorders, history or family history of QT prolongation, significant bradycardia, recent acute myocardial infarction, uncompensated heart failure, cardiac arrhythmia. or angina pectoris.

    Use with caution in patients with risk factors for stroke.
    There is a possibility of increased risk of cerebrovascular adverse events in the dementia population

    Narrow angle glaucoma

    Myasthenia gravis

    Prostatic hypertrophy

    Epilepsy and conditions predisposing to epilepsy

    Severe respiratory disease

    History of jaundice including cholestatic jaundice

    Avoid abrupt discontinuation, potential for acute withdrawal symptoms such as nausea, vomiting, sweating and insomnia. Recurrence of antipsychotic symptoms may occur.

    Emergence of involuntary movement disorders such as akathisia, dystonia and dyskinesia. Consider discontinuation if signs of tardive dyskinesia occur.

    Discontinue if neuroleptic malignant syndrome occurs

    Long term therapy - patient should be regularly monitored

    Symptoms may be worsened in patients with parkinson's disease and the effects of levodopa reversed.

    Nausea and vomiting as a sign of organic disease may be masked by the anti-emetic action of trifluoperazine.

    A three fold increase in the risk of cerebrovascular adverse effects in the dementia papulation has been observed. Use with caution in patients with risk factors for stroke.

    Monitor patients on long term therapy for possible eye changes, hepatic impairment, myocardial conduction defects and blood dyscrasias.

    Perform blood counts if unexplained infection or fever develops.

    Photosensitisation may occur with higher doses therefore patients should avoid direct sunlight.

    Patients who demonstrated bone marrow suppression or jaundice with a phenothiazine should not be re-exposed to trifluoperazine.

    May affect body temperature control.

    Some formulations contain sorbitol and malitol so unsuitable for use in patients with hereditary fructose intolerance.

    Some formulations contain methyl and propyl hydroxybenzoate which may cause allergic reactions (possibly delayed).

    Some formulations contain sucrose (icing sugar) so unsuitable for use in patients with glucose-galactose malabsorption syndrome.

    May impair alertness, especially at the start of treatment or following alcohol consumption, so patients should be warned of the risk and advised not to drive or operate machinery until their individual susceptibility is known.

    Pregnancy and Lactation

    Pregnancy

    Use with caution in pregnancy.

    Trifluoperazine readily crosses the placenta.

    There are several reports of exposed pregnancies. The potential risks in humans is unknown as there are conflicting reports of possible congenital defects associated with trifluoperazine use in human pregnancies. No foetal adverse effects have been observed in rabbits or monkeys given many times the normal human dose. However some studies in rats showed an increased incidence of malformations and reduced litter size and weight. Schaefer concludes that inadvertent exposure to trifluoperazine at any stage in pregnancy is not considered an indication for termination of the pregnancy or for invasive diagnostic procedures. Briggs concludes that the bulk of evidence suggests that the drug is safe for the mother and low risk for embryo / foetus.

    Neonates exposed to antipsychotics during the third trimester are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms. Monitor neonates carefully as there have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorders.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

    Licensed in pregnancy? - No

    Recommended for use in pregnancy? - No

    Animal data - Suggests low risk

    Crosses placenta? - Yes

    Lactation

    Use with caution in breast feeding.

    At the time of writing, there is limited published experience concerning the use of trifluoperazine during breastfeeding. Limited information indicates that maternal doses of trifluoperazine up to 10mg daily do not affect the breastfed infant, however as there is little published experience and no long term follow up data concerning breastfed infants other antipsychotic agents may be preferred. It's molecular weight is low enough to suggest passage into breast milk. Minor adverse effects have been described with other Phenothiazines.

    NICE advises that Infants of mothers who are breastfeeding while taking psychotropic medication should be monitored for adverse reactions.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

    Drug excreted in breast milk? - Molecular weight is low enough to suggest passage into breast milk.

    Considered suitable or recommended by manufacturer? - No

    UK Drugs in Lactation Advisory Service Classification - Phenothiazines, minor adverse effects have been described.

    Effects on Ability to Drive and Operate Machinery

    Patients who drive or operate machinery should be warned of the possibility of disturbances of the central nervous system.

    Counselling

    Patients who drive or operate machinery should be warned of the possibility of disturbances of the central nervous system.

    Side Effects

    Agitation
    Akathisia
    Anorexia
    Antimuscarinic effects
    Apathy
    Subjective feelings of mental slowness or dullness
    Cardiac arrest
    Cardiovascular effects
    Confusion
    Contact sensitisation
    Convulsions
    Corneal opacities
    Dizziness
    Drowsiness
    Deep vein thrombosis (DVT)
    Dyskinesia
    Dystonia
    ECG changes
    Excitement
    Extrapyramidal effects
    Galactorrhoea
    Gastro-intestinal disturbances
    Gynaecomastia
    Headache
    Hyperprolactinaemia
    Hyperpyrexia
    Hypotension
    Interference with temperature regulation
    Impotence
    Insomnia
    Jaundice
    Lassitude
    Lens opacities
    Menstrual disturbances
    Cholestatic jaundice
    Muscle weakness
    Nasal congestion
    Neuroleptic malignant syndrome
    Oedema
    Parkinsonism
    Pulmonary embolism
    Photosensitivity
    Glaucoma
    Prolongation of QT interval
    Purplish pigmentation of cornea, conjunctiva, retina
    Purplish pigmentation of skin
    Rash
    Retinopathy
    Skin pigmentation changes
    Skin reactions
    Sweating
    Torsades de pointes
    Restlessness
    T-wave changes
    Venous thrombosis
    Ventricular arrhythmias
    Ventricular fibrillation
    Ventricular tachycardia
    Weight gain
    Sudden unexplained death
    Neonatal withdrawal syndrome

    Withdrawal Symptoms and Signs

    Acute withdrawal symptoms, including nausea, vomiting, sweating and insomnia have been described after abrupt cessation of antipsychotic drugs. Recurrence of psychotic symptoms may occur, and the emergence of voluntary movement disorders such as akathisia, dystonia and dyskinesia have been reported.
    Therefore gradual withdrawal is advisable.

    Overdosage

    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

    Shelf Life and Storage

    Do not store above 25 degrees C
    Store in the original packaging
    Store in a dry place
    Protect from light
    Discard one month after opening
    Discard after twelve months if unopened (applies to liquid product only)

    Further Information

    Last Full Review Date: May 2011

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 8th edition (2008) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

    Martindale: The Complete Drug Reference, 36th edition (2009) ed. Sweetman, S. Pharmaceutical Press, London.

    Summary of Product Characteristics: Stelazine 1mg Tablets. Goldshield. Revised December 2011.

    Summary of Product Characteristics: Stelazine 5mg Tablets or Trifluoperazine 5mg Tablets. Goldshield. Revised December 2011.

    Summary of Product Characteristics: Stelazine Syrup. Goldshield. Revised December 2011.

    Summary of Product Characteristics: Trifluoperazine 5mg/5ml Oral Solution. Rosemont. Revised July 2010

    NICE Evidence Services Available at: www.nice.org.uk Last accessed: 04 September 2017

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
    Trifluoperazine. Last revised: Jan 4, 2011
    Last accessed: May 4, 2011.

    UK Drugs in Lactation Advisory Service.
    Available at: https://www.ukmicentral.nhs.uk/drugpreg/qrg_p1.asp
    Last accessed: May 4, 2011

    Antenatal and postnatal mental health. Clinical management and service guidance (Dated April 2007, review of new evidence: 2 years after this date).
    Available at https://www.nice.org.uk/nicemedia/pdf/CG045NICEGuidelineCorrected.pdf
    Accessed May 4, 2011

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